Method of configuring blood circuit for medical application and configuration apparatus therefore

ABSTRACT

In a method of configuring a blood circuit for medical application, one unit component is selected for each of the divided unit sections and the selected unit components are combined to configure a blood circuit component. A blood circuit system database in which data with respect to the unit sections and unit components are stored is used. On the basis of the database, the selected unit component input to the computer. An assembly drawing of the blood circuit obtained by combining the selected unit components, a full length and an amount of filled blood are displayed on a display by using the database. When the displayed assembly drawing etc. is not fit for the desired specification, the selection of the unit component is changed, so as to display again the assembly drawing etc. of the blood circuit.

This application is a Division of Ser. No. 09/870,103 filed on May 30,2001 now U.S. Pat. No. 6,629,005.

FIELD OF THE INVENTION

The present invention relates to a method of configuring a blood circuitfor medical application. In more detail, it relates to a method ofconfiguring a desired blood circuit for medical application on acomputer by systematizing many components constituting the blood circuitinto a plurality of unit sections and selecting a component in each unitsection.

BACKGROUND OF THE INVENTION

A blood circuit for medical application includes a blood circuit usedfor, for example, a dialysis. The dialysis requires not only a dialyzerbut also a blood circuit for connecting a patient to the dialyzer.Conventionally, this blood circuit for dialysis varies in specificationsdepending upon users, i.e., hospitals, doctors, or laboratorytechnicians. That is, most of the conventional blood circuits arecustomized for individual users and do not have general versatility.Actually, a large number of different kinds of blood circuit systems areemployed.

Since such blood circuits are customized for individual users, the costis high and it takes a long time to deliver the products to users. Inother words, it takes a long time to configure a circuit by repeatingtrials and errors, which may lead to increased cost. A more importantproblem is that a dialysis technique is dependent on the experience ofin the individual person in charge such as a doctor, a laboratorytechnician, etc., and a method of connecting each machine to the circuitsystem and a method of using the circuit system are not systematized.Therefore, a circuit system may be changed subjectively by theindividual person in charge. Furthermore, compatibility betweendifferent products is not established. Thus, there are problems insafety as a product used directly on the human body. Examples of suchproblems are a safety problem, for example, failure in fitting of a toolsuch as an indwelling needle, etc. that is connected to the circuit, anda lack of versatility, that is, because of a difference in length evenon the order of only several centimeters, such an apparatus has to beproduced based on a different standard.

On the other hand, with the stability of the performance of dialyzers inrecent years, the safety of blood circuits, ease of using, andeconomical efficiency are becoming problems. In order to solve suchproblems, it is urgently demanded to standardize various componentsconstituting a blood circuit and to provide the stability in quality,convenience, and rapidity in configuring a circuit.

With respect to the demand, JP63 (1988)-95063A proposes that eachcomponent is integrated into one piece of a packaged system. However,this proposal has disadvantages in that equipment being connected to thecircuit system has less versatility, and that the system is not usedconveniently.

Furthermore, there are about 3400 types of blood circuits only in Japan.Conventionally, problems with respect to the conveniences in using, forexample, length, location of parts, etc., are adjusted by trial anderror and samples are made and attached to a dialyzer. In other words,the adjustments have been carried out by using a real machine.

In order to make samples, it is necessary to make a standard drawing andoften calculate the amount of filled blood or length based on thestandard drawing. If defects are detected in the test by the use of realmachines, there is a bother to start again from the formation ofstandard drawings.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a method of easilyconfiguring a blood circuit for medical applications, which is capableof configuring a blood circuit in accordance with the applications.

It is another object of the present invention to provide a method ofconfiguring a blood circuit for medical applications, which is capableof checking efficiently whether the circuit is fit for a desiredspecification or not, or capable of efficiently correcting the bloodcircuit configuration without actually assembling a sample, and anapparatus used for the configuring method.

In the method of configuring the blood circuit for medical applicationof the present invention, a blood circuit system is formed by dividing ablood circuit into a plurality of sections and preparing a plurality ofselectable unit components for at least one unit section. By selectingat least one unit component from each unit section and combining theselected unit components, an individual blood circuit is configured. Forconfiguration, the method includes using a blood circuit system databasein which data with respect to the unit sections and the unit componentscontained in the blood circuit system are stored, inputting one of theunit sections on a basis of the blood circuit system database as anassigned unit section to the computer, extracting the data of aplurality of the corresponding unit components from the blood circuitsystem database by the computer based on the input assigned unit sectionand displaying the extracted data on a display, and inputting onecomponent selected from the displayed unit components as a selected unitcomponent to the computer. After carrying out the above-mentionedprocedures in the necessary unit section, by the use of the bloodcircuit system database, an assembly drawing showing an entireconfiguration of the blood circuit obtained by combining the inputselected unit components and at least one of a full length of the bloodcircuit or an amount of filled blood are displayed on a display. Then, acommand for changing the selection of the unit components or a commandfor determining the configuration of the blood circuit is input to thecomputer.

According to this method, by only selecting the unit component inaccordance with the unit section, it is possible to configure the bloodcircuit in accordance with the applications easily. Moreover, withoutconstructing a real sample of the blood circuit, it is possible to checkwhether the circuit is fit for the desired specification or not.Furthermore, in a case where the sample is not fit for the desiredspecification, only by changing the selection of the unit components, itis possible to check whether the reconfigured sample is fit for thedesired specification promptly. Since the blood circuit system can beproduced by dividing a plurality of reasonable unit sections from theviewpoint of techniques in dialysis, it is possible to clarifyindividual features of each unit component. Therefore, it is useful toselect unit components appropriately in accordance with theapplications.

The above-mentioned method of configuring a blood circuit for medicalapplication further includes, after the procedure of inputting theselected unit components to the computer, selectively either returningto the procedure for inputting the assigned unit section or inputting aselection terminating command for terminating the input of the selectedunit components and going to the following procedures; when theselection terminating command is input, if there is any unit sectionwith no selected unit component input, returning to the procedure ofinputting the assigned unit section; and if the selected unit componenthas been input in all the unit sections, going to the followingprocedures, and if the selection of the unit component is to be changed,returning to the procedures of inputting the assigned unit section.

In the above-mentioned method, if the command of determining theconfiguration of the blood circuit is input, based on the blood circuitsystem database, the price of the blood circuit obtained by combiningeach selected unit component is displayed on the display.

Furthermore, it also is desirable that an existing standard database inwhich a plurality of existing standards are stored is used, the existingstandard being a plurality of the combination of unit componentsconstituting an existing specific blood circuit, and when an assemblydrawing, a full length of the blood circuit and an amount of filledblood are displayed, the existing standard being analogous to theconfiguration of the displayed blood circuit is retrieved and displayedas an analogous standard. Thus, when the existing standard that complieswith a desired specification is present, it is not necessary to producea blood circuit based on a new standard, and thus, the blood circuit canbe produced efficiently and economically.

Another method of configuring a blood circuit for medical application ofthe present invention includes a blood circuit system that is the sameas the above, and uses a similar blood circuit system database. Themethod includes: inputting set conditions including a price with respectto the blood circuit to be configured to the computer; and extracting apredetermined range of candidates of the combinations of the unitcomponents from the blood circuit system database based on the degree ofthe compliance with the input set conditions. A list of the candidatesof the combinations of the extracted unit components is displayed on adisplay, and a selected assignment of one combination selected from thecandidates of the displayed combinations is input to the computer. Next,an assembly drawing of an entire configuration of the blood circuitobtained by combining the selected unit components and at least one of afull length of the blood circuit or an amount of filled blood aredisplayed on the display in accordance with the input of the selectedassignment by the use of the blood circuit system database.

According to this method, it is possible to determine the combinationsof unit components constituting a blood circuit easily based on the setconditions from an economical viewpoint or a productive viewpoint.

In the above-mentioned method, it also is desirable that an existingstandard database in which a plurality of the existing standards arestored is used, the existing standard being a plurality of thecombination of the unit components constituting an existing specificblood circuit. When the candidates of the combinations of the unitcomponents are extracted, an existing standard of the combination havinga high degree of the compliance with the set conditions are extractedalso from the existing standard database and added to the predeterminedrange of the candidates of the unit components.

A first apparatus for configuring a blood circuit for medicalapplication of the present invention is an apparatus for configuring ablood circuit for medical application based on the blood circuit system,and includes the above-mentioned blood circuit system database. Theapparatus further includes a unit section assignment portion forinputting one unit section on the basis of the blood circuit systemdatabase as an assigned unit section; a unit component display portionfor extracting data of a plurality of the unit components correspondingto the input assigned unit section and displaying the extracted data; aunit component selection portion for inputting one unit componentselected from the displayed unit components, maintaining the data of theselected unit component of all the unit sections, and supplying themaintained data as data of the combination of the selected unitcomponents; and an assembly drawing etc. display portion for displayingan assembly drawing and at least one of a full length of the bloodcircuit or an amount of filled blood on the display. In the apparatus,the data of the selected unit component in the unit component selectingportion can be changed by assigning the unit section in the unit sectionassignment portion.

It is desirable that the apparatus having the above-mentionedconfiguration further includes an existing standard database in which aplurality of the existing standards are stored, the existing standardbeing the combination of the unit components constituting an existingspecific blood circuit, an analogous standard retrieving portion forretrieving a blood circuit that is analogous to the combination of theselected unit components from the existing standard database on a basisof the data supplied from the unit component selection portion, and ananalogous standard selection portion having a function of selecting onefrom the retrieved existing standards by the analogous standardretrieving portion, and instead of in the unit component selectionportion, supplying the data of the combinations of the selected unitcomponents on the basis of the selected existing standard to theassembly drawing etc. display portion.

A second apparatus for configuring a blood circuit for medicalapplication of the present invention, similar to the first apparatus, isan apparatus for configuring a blood circuit based on theabove-mentioned blood circuit system and includes: the above-mentionedblood circuit system database. Furthermore, the second apparatusincludes a set conditions input portion for inputting the set conditionsincluding a price with respect to the blood circuit to be configured; aretrieved combination candidate display portion for, by the use of theblood circuit system database, retrieving candidates of the combinationsof the unit components based on the degree of the compliance with theinput set conditions, extracting the predetermined range of theretrieved candidates of the combinations of the unit components, anddisplaying the extracted candidates of the combinations; a selectionassignment portion for selecting and supplying one of the candidates ofthe combinations of the extracted unit components to an assembly drawingetc. display portion as data of the combinations of the selected unitcomponents; and an assembly drawing etc. display portion for displayingan assembly drawing showing an entire configuration of the blood circuitand at least one of a full length of the blood circuit or an amount offilled blood on the display by the use of the blood circuit systemdatabase on the basis of the data of the combinations of the selectedunit components.

It is desirable that the apparatus having this configuration furtherincludes an existing standard database in which a plurality of theexisting standards are stored, the existing standard being thecombination of the unit components constituting an existing specificblood circuit, wherein the retrieved combination candidate displayportion retrieves the existing standard database together with the bloodcircuit system database.

Furthermore, it is desirable that the apparatus for configuring theblood circuit includes the above-mentioned first apparatus and thesecond apparatus and includes an operation selection portion forselecting any one of an operation by the unit section assignment portionor an operation by the set conditions input portion.

In the method of configuring the blood circuit for medical applicationor a configuration apparatus mentioned above, the blood circuit formedical application is a blood circuit for dialysis and the bloodcircuit is divided into an artery side circuit and a vein side circuit,further each of the artery side circuit and the vein side circuit isdivided into a plurality of unit sections.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flow chart showing a method of configuring a blood circuitfor medical application according to a first embodiment of the presentinvention.

FIG. 2 is a block diagram showing an apparatus for configuring a bloodcircuit for medical application according to the first embodiment of thepresent invention.

FIG. 3 is a flow chart showing a method of configuring a blood circuitfor medical application according to a second embodiment of the presentinvention.

FIG. 4 is a block diagram showing an apparatus for configuring a bloodcircuit for medical application according to the second embodiment ofthe present invention.

FIG. 5 is a block diagram showing an apparatus for configuring a bloodcircuit for medical application according to a third embodiment of thepresent invention.

FIG. 6 is a plan view showing an example of unit sections of a bloodcircuit for medical application according to the present invention.

FIGS. 7A to 7F are plan views showing examples of unit componentsapplied to a unit section A.

FIGS. 8A to 8D are plan views showing examples of unit componentsapplied to a unit section B.

FIGS. 9A to 9D are plan views showing examples of unit componentsapplied to a unit section C.

FIGS. 10A to 10C are plan views showing examples of unit componentsapplied to a unit section D.

FIGS. 11A to 11D are plan views showing examples of unit componentsapplied to a unit section E.

FIGS. 12A to 12B are plan views showing examples of unit componentsapplied to a unit section F.

FIGS. 13A to 13D are plan views showing examples of unit componentsapplied to a unit section G.

DETAILED DESCRIPTION OF THE INVENTION

(First Embodiment)

FIG. 1 is a flow chart showing a method of configuring a blood circuitfor medical applications of a first embodiment. This method is employedfor, for example, a blood circuit system shown in FIGS. 6 to 13.

FIG. 6 shows one example of a formation of unit sections in a bloodcircuit system for dialysis. In this system, the blood circuit isdivided into an artery side circuit and a vein side circuit. Each of theartery side circuit and the vein side circuit is further divided so asto form unit sections A to G. Herein, the artery side circuit denotes acircuit constituting a portion between a connection portion of anindwelling needle at the artery side and a connection portion of adialyzer when a dialysis is carried out. On the other hand, the veinside circuit denotes a circuit constituting a portion between aconnection portion of the dialyzer and a connection portion of anindwelling needle side at the vein side when dialysis is carried out. Asshown in FIGS. 7 to 13, each unit section is provided with a pluralityof selectable unit components, for example, a unit component A-1, a unitcomponent A-2, etc. Each unit component is usually composed of aplurality of components. The definition of each unit section and thefeatures of each unit section are described hereafter.

In the thus configured blood circuit system, at least one unit componentis selected from the unit sections A to G, and the selected unitcomponents are combined so as to configure a blood circuit. FIG. 1 showsa method of combining unit components efficiently and properly by theuse of a computer in configuring the blood circuit in this way. Thisembodiment will be explained with reference to the blood circuit systemsshown in FIGS. 6 to 13.

In order to carry out this configuring method, a blood circuit systemdatabase in which data with respect to unit sections and unit componentscontained in a blood circuit system are stored is constructed on acomputer. The contents contained in the data includes, for example, ashape, size, data related to a production cost, etc. of each unitcomponent classified in each unit section.

As shown in FIG. 1, first, by using a blood circuit system database, onesection is selected from the unit sections A to G shown in FIG. 6 andthe selected section is input to the computer as an assigned unitsection (step S101). Based on the input assigned unit section, aplurality of the corresponding unit components are retrieved from theblood circuit system database and displayed on a display (step S102).One unit component is selected from the displayed unit components andinput as the selected unit component (step S103).

Next, selection is carried out between returning to step S101 or goingto step S104.

In the case of returning to step S101, the selected unit component isinput by assigning an unselected unit section in which no selected unitcomponent is input. In this way, one unit component is selectedappropriately in each unit section from a plurality of the stored unitcomponent data. By repeating this procedures, unit components areselected for all the unit sections A to G. Alternately, it is alsopossible to assign the previously selected unit section again so as tochange the selection of unit components.

In step S104, a selection terminating command is input for terminatingthe input of the selected unit components. When the selectionterminating command is input, the processing splits depending uponwhether an unselected unit section is present or not (step S105). Whenan unselected unit section is present, the processing is returned to theprocedure for inputting the assignment of the unit section (step S101),and when the selected unit component is input for all the selected unitsections, the processing goes to the following procedure (step S106).

In step S106, based on the blood circuit system database, an assemblydrawing showing an entire configuration of the blood circuit in whichthe selected unit components are combined, and a full length of theblood circuit and the amount of filled blood are displayed on a display.The assembly drawing, the full length of the blood circuit and theamount of filled blood are formed or calculated each time based on thedata of each unit component. Alternately, it is possible to prepare inadvance, all the sets of an assembly drawing, a full length of the bloodcircuit and the amount of filled blood corresponding to all thecombinations of the unit components and display one of the setsaccording to the selected unit components. Among the contents to bedisplayed, the assembly drawing is essential, but at least one of thefull length and the amount of filled blood may be displayed togetherwith the assembly drawing.

Next, a processing is selected based on whether the configuration of thedisplayed blood circuit is corrected or not, i.e., the selected unitcomponents are changed or not. Whether the configuration of the bloodcircuit is corrected or not is judged by verifying conditions, forexample whether the constructed blood circuit has a length fit for thedialyzer to be used or not, or the amount of filled blood is appropriateor not, etc. Therefore, in step S106, as the full length and the amountof filled blood are displayed together with the assembly drawing, theverification can be carried out efficiently. Furthermore, in addition tothe above-mentioned items, if the total weight, volume (bulk) and thelike are displayed, it is possible to consider so as to allow the amountof waste to be reduced.

When the configuration of the blood circuit is to be corrected, theabove-mentioned procedures are repeated by returning to the procedurefor inputting the assignment of a unit section (step S101). When theconfiguration of the blood circuit is not to be corrected, a command fordetermining the configuration of the blood circuit is input to thecomputer (step S107). When the command of determining the configurationof the blood circuit is input, based on the blood circuit systemdatabase, the price of the blood circuit in the combination of selectedunit components is calculated and displayed on the display (step S108).Thus, it is possible to investigate the constructed blood circuit fromthe economical aspect. However, step 108 is not an essential step forthis embodiment.

According to the above-mentioned method, by only selecting the unitcomponent with respect to the unit section, it is possible to configurethe blood circuit in accordance with the applications easily. Moreover,without constructing the sample actually, it is possible to checkwhether the circuit is fit for the desired specification or not.Furthermore, if the circuit is not fit for the desired specification,only by changing the selection of the unit component for a part of theunit section, the compliance with the reconfigured blood circuit can bechecked promptly.

Moreover, it is more effective to construct and use an existing standarddatabase in addition to the blood circuit system database. The existingstandard is defined as the combination of the unit componentsconstituting the existing specific blood circuit. The existing standarddatabase is constructed by storing a plurality of such existingstandards. Thus, for example, the existing standard analogous to theconfiguration of the blood circuit displayed in step S106 is retrievedand displayed as an analogous standard. If the analogous standard ishighly compliant with the desired specification, instead of configuringa new blood circuit, the existing blood circuit is selected. Therefore,since it is not necessary to make a new standard, and it is possible toprovide a blood circuit more efficiently and more economically.

FIG. 2 shows an apparatus for configuring a blood circuit for medicalapplications for carrying out the above-mentioned method. Numeral 201denotes a blood circuit system database. A unit section assignmentportion 202 has a function of inputting one of the unit sections basedon the blood circuit system database 201 as a assigned unit section. Ina unit component display portion 203, data of a plurality of unitcomponents corresponding to the input assigned unit section areextracted from the blood circuit system database 201 and displayed on adisplay (not shown). A unit component selection portion 204 has afunction of selecting one of the unit components, displayed by the unitcomponent display portion 203, inputting the selected component andmaintaining the data of the selected unit component for all the unitsections. By repeating the procedures by the unit section assignmentportion 202, the unit component display portion 203 and the unitcomponent selection portion 204, the selection of the unit component iscarried out for all the unit sections. The change of the unit componentthat was once selected is carried out by assigning the unit section tobe changed again by the unit component assignment portion 202. Theselected data maintained in the unit component selection portion 204 issupplied as the data of the combination of the selected unit component.

An assembly drawing etc. display portion 205 displays an assemblydrawing, a full length of the blood circuit, and an amount of filledblood based on the data of the combination of the selection unitcomponents supplied from the unit component selection portion 204 by theuse of the blood circuit system database 201. In accordance with thedisplayed contents such as the assembly drawing, etc., if necessary, asmentioned above, starting from the operation by the unit sectionassignment section 202, the data of the selected unit in the unitcomponent selection portion 204 is changed. As to the resultantreconfigured blood circuit, the assembly drawing, etc. can be displayedimmediately.

FIG. 2 shows an existing standard database 206, an analogous standardretrieving portion 207 and an analogous standard selection portion 208in addition to the above-mentioned basic configuration.

As mentioned above, the existing standard database 206 is defined as thecombination of the unit component constituting the existing specificblood circuit. The existing standard database is constructed by storinga plurality of such existing standards. The analogous standardretrieving portion 207 retrieves the blood circuit analogous to thecombination of the selected unit components from the existing database206 based on the data supplied from the unit component selection portion204. An analogous standard selection portion 208 has a function ofselecting one from the plurality of existing standards retrieved by theanalogous standard retrieving portion 207 and supplies the combinationdata of the selected unit components instead of the data supplied fromthe unit component selection portion 204 to the assembly drawing etc.display portion 205.

Second Embodiment

FIG. 3 is a flow chart showing a method of configuring a blood circuitfor medical application of the second embodiment of the presentinvention. According to the method shown in FIG. 3, unlike the methodshown in the first embodiment, a unit component is not selected for eachunit section. Instead, conditions such as price etc. are input first,and then the combinations of the unit components satisfying theconditions are extracted from the blood circuit system database, andthus the blood circuit is configured.

Furthermore, the existing standard database described in the firstembodiment is constructed and used together with the blood circuitsystem database. However, this existing standard database is notessential for this embodiment, and therefore can be omitted.

In FIG. 3, first, the set price of the blood circuit is input (stepS301). At the same time, it is desirable that in addition to the setprice, other set conditions, for example, necessary quantities,desirable delivery period, specification of the circuit and the like canbe input.

Next, based on the input set conditions, some of the combinations of theunit components having the highest compliance with the set conditionsare extracted by retrieving the blood circuit system database (stepS302). The number of extracted combinations may be limited to theappropriate number by giving a higher priority to the combination havinghigher degree of compliance. Furthermore, the system may be constructedin a manner such that the retrieval is carried out based on the limiteditem (number) of the above-mentioned set conditions and predeterminedpriority of the items.

Furthermore, at the same time, from the existing standard database, onehaving a higher compliance with the set conditions is extracted (stepS303). The reason why the retrieving is also carried out in the existingstandard is because if the blood circuit is selected from the existingstandard it is possible to produce an apparatus in a short time andbecause the use of the existing unit components can reduce the price.

Next, the retrieved results are displayed as a candidate list (stepS304). From the displayed candidates, the combination of the unitcomponents is selected appropriately (step S305). Based on the selectedcombination, like in the case of FIG. 1, an assembly drawing, the lengthof the circuit and the amount of filled blood are displayed on thedisplay (step S306). When the content of the displayed blood circuit iswithin the acceptable range with respect to the set conditions of theblood circuit, an input for determining the configuration of the circuit(step S307) is carried out.

By the method mentioned above, it is possible to determine easily thecombination of the unit components constituting the blood circuit, basedon the requirements from the economical aspect or productivity aspect.

FIG. 4 shows an apparatus for configuring a blood circuit for medicalapplication for carrying out the above-mentioned method. The bloodcircuit system database 201, the assembly drawing etc. display portion205, and the existing standard database 206 are the same as in FIG. 2.

A set conditions input portion 401 has a function for inputting the setconditions such as prices, etc. with respect to the blood circuit to beconfigured. In the combination candidate retrieving display portion 402,candidates of the combinations of the unit components based on thedegree of compliance with the input set conditions by the use of theblood circuit system database 201 are extracted and displayed. Thenumber of the candidates of the combinations of the extracted unitcomponents is limited to an appropriate number by giving a higherpriority to higher compliance. The selection assignment portion 403 hasa function of selecting one from the candidates of the combinations ofthe extracted unit components and supplying the extracted candidate toassembly drawing etc. display portion 205 as the data of thecombinations of the selected unit components. As mentioned above, ablood circuit is configured based on the set conditions input from theset conditions input portion 401.

In addition to the basic functions, the retrieving of the combinationcandidates by the combination candidate retrieving display portion 402is carried out also with respect to the existing standard database 206.Namely, the existing standard having a high compliance with the setconditions is extracted and displayed together with the new combination.

Third Embodiment

It is more practical to configure an apparatus capable of usingselectively the method of the first embodiment and the second embodimentinstead of using a single method. That is, the configuration method ofthe blood circuit includes the case where the circuit is intended to beset from the specification of the circuit, and the case where theconfiguration of the circuit is intended to be selected from theeconomical aspect such as a price. It is desirable to comply withrequests of both cases. Furthermore, by using two methods selectively,it is possible to configure a blood circuit efficiently by taking notonly the requirement as the function of the circuit but also theconditions from the business aspect or manufacturing aspect intoaccount.

FIG. 5 shows an apparatus capable of carrying out the two processes,selectively. In this figure, the same element as that shown in FIGS. 2and 4 is provided with the same reference numeral and the explanationtherefor is not repeated herein. Moreover, although in this figure, onlythe basic functional portions without using an existing standarddatabase are shown, it is possible to configure the apparatus so thatthe existing standard database further is used.

This apparatus is provided with an operation selection portion 404capable of selecting an operation by the unit section assignment portion202 or an operation by the set conditions input portion 401. When theoperation by the unit section assignment portion 202 is selected, it ispossible to configure the blood circuit by selecting the unit componentsin each unit section. On the other hand, when the operation by the setconditions input portion 401 is selected, it is possible to configurethe blood circuit by appropriately selecting the candidate of thecombinations of the unit components based on the input set conditions.

The following are explanations for the formation of the unit sectionsshown in FIG. 6 in the blood circuit system for medical application usedin the above-mentioned embodiments.

[Artery Side Circuit]

Unit section A: The unit section A includes a tube having a cannulaconnector connected to an artery side indwelling needle as a maincomponent and also includes a mixing/charging port and a lock-nutconnector or a non-locking connector.

Unit section B: The unit section B connects the unit section A and aunit section C and includes a tube for adjusting the length as a maincomponent. A branched tube connector that is connected to the belowmentioned unit section D or the unit section E is attached to the unitsection B.

Unit section C: The unit section C is located between the unit section Band a dialyzer and includes a liquid feeding pump tube attached directlyto a negative pressure detection part and a blood pump apparatus, anartery chamber, a dialyzer connector, and a branched tube connector. Apressure monitor line and a blood level adjusting line are connected tothe branched tube connector. A mixing/charging port may be provided inthe unit section C.

Unit section D: The unit section D is connected to the branching tubeconnector of the unit section B or the unit section C, includes aconnector capable of being connected to a container containing a bloodanticoagulant and has a tube length that is adjusted to the settinglocation of the blood anticoagulant supply apparatus.

Unit section E: The unit section E is attached to the tip portion of theunit section A, the unit section B, or unit section C. The unit sectionE is a line used for priming before dialysis or replacement of a drugsolution during dialysis. The unit section E includes a connectorcapable of being connected to a needle for punctuating a drug solutioncontainer or other drug solution infusion tool, and a means foropening/closing the line.

[Vein Side Circuit]

Unit section F: The unit section F is located between the unit section Gand a dialyzer, and includes a vein changer being selectable by thedialysis conditions, such as the nature of blood, flow rate of blood orthe like, a pressure monitor line, a liquid level adjusting line, and amixing/charging port.

Unit section G: The unit section G includes a cannula connectorconnected to a vein side indwelling needle as a main component, andfurther includes selection units of a plurality of tube diameters, amixing/charging port, a lock-nut connector or a non-locking connector.

The following are explanations of the examples of each unit componentapplied to the unit sections A to G.

(Unit Section A)

FIGS. 7A and 7D show the unit components applied to the unit section A.The unit component A-1 shown in FIG. 7A includes an artery side cannulaconnector 1, a cover 2 for the artery side cannula connector 1, a bloodcollecting mixing/charging port 4 and a tube connecting between theartery side cannula connector 1 and the blood collecting mixing/chargingport 4. The artery side cannula connector 1 is used for being connectedto a scalpel connector such as an indwelling needle inserted into apatient. The blood-collecting mixing/charging port 4 is used forcollecting blood for testing or for infusing a drug solution.

The artery cannula connector 1 is covered with the cover 2 at the timeof priming and just before the dialysis, as shown in FIG. 7B has thecover 2 taken off and is connected to the indwelling needle 9 (see FIG.7C). Blood can be collected from the upper part 5 of the mixing/chargingport 4.

The unit component A-2 shown in FIG. 7D is provided with a lock nutbetween the artery side cannula connector 1 and the mixing/charging port4 of the unit component A-1. Numeral 8 denotes a connecting line. Thelock nut 6 is temporarily fixed to a lock portion 7 when it is not used.However, as shown in FIG. 7E, it can be shifted to the location of theartery side cannula connector 1 by hand. Since the screw is providedinside the lock nut 6, it can be connected to the artery side cannulaconnector 1 so as to be locked to a winged indwelling needle 9 (see FIG.7F).

(Unit Section B)

FIGS. 8A to 8D show unit components applied to the unit section B.

First, a unit component B-1-1 is a resin tube 11 having a full length ofabout 600-1000 mm (FIG. 8A). A unit component B-1-2 is a resin tube 12having a full length of about 1000-1600 mm (FIG. 8).

In the case where the drug solution is replaced from the branched tubebranching for fluid replacement in this unit section B, as shown in theunit component B-2-1 (FIG. 8) and the unit component B-2-2 (FIG. 8D), atube provided with a branched tube connector 13 is used.

(Unit Section C)

FIGS. 9A to 9D show the unit components useful for the unit section C. Aunit component C-1-1 (FIG. 9A) is provided with a pump tube 21 having anouter diameter of 12 mm and a length of about 250-350 mm, and an arterychamber 23 including a mesh filter 24. The artery chamber 23 is anelement for pulling out the air entering the dialyzer in order toprevent the contamination of the blood by air. Numeral 25 is a branchedtube connector, 26 denotes a dialyzer connector, and 27 denotes anegative pressure detection portion. The negative pressure detectionportion 27 is a portion for informing abnormality when it is broken atthe time of deficiency in removing the blood during the dialysis. Thebranched tube connector 25 may be used only by attaching the liquidsolution replacement line or a drug solution infusion line.

A unit component C-1-2 (FIG. 9B) is provided with a pump tube 22 havingan outer diameter of 10 mm and a length of about 250-350 mm, and anartery chamber 23 including a mesh filter 24 like the unit componentC-1-1.

Similar to the unit component C-1-1, the unit component C-2-1 (FIG. 9C)is provided with a pump tube 22 having an outer diameter of 12 mm and alength of about 250-350 mm, and an artery chamber 29. However, in theunit component C-2-1, the artery chamber 29 does not have a mesh filterfor miniaturization.

Similar to the unit component C-1-2, the unit component C-2-2 (FIG. 9D)is provided with a pump tube 22 having an outer diameter of 10 mm and alength of about 250-350 mm, and an artery chamber 29. However, in thiscomponent, the artery chamber 29 does not have a mesh filter forminiaturization.

In any of the types, a small-diameter tube 28 may be used for a mainline so as to reduce the priming amount.

(Unit Section D)

FIGS. 10A to 10C show the unit components applied to the unit section D.

A unit component D-1 (FIG. 10A) is an anticoagulant infusion lineprovided with a tube 31 having a full length of about 200-400 mm and anouter diameter of about 1.5-4 mm and a connector 34 that can beconnected to a container containing a blood anticoagulant. Theanticoagulant infusion line is used for infusing drug preventing thecoagulation of the blood during the dialysis. This unit component canprevent the excessive absorption of the drug solution due to negativepressure by arranging it behind the pump tube. For example, the unitcomponent can be connected to the branched tube connector 25 of the unitcomponent C-1-1 shown in FIG. 9A.

A unit component D-2 (FIG. 10B) is an anticoagulant infusion lineprovided with a tube 32 having a full length of about 400-600 mm and anouter diameter of about 1.5-4 mm and a connector 34 that can beconnected to a container containing a blood anticoagulant. The unitcomponent D-2 matches to a console set-up type syringe pump and is themost suitable for the general dialysis.

A unit component D-3 (FIG. 10C) is an anticoagulant infusion lineprovided with a tube 33 having a full length of about 600-1000 mm and anouter diameter of about 1.5-4 mm and a connector 34 that can beconnected to a container containing a blood anticoagulant.

(Unit Section E)

FIGS. 11A to 11D show the unit components applied to the unit section E.

The unit component E-1-1 (FIG. 11A) is a straight type liquidreplacement line for a drug solution. Numeral 41 denotes a drip infusioncylinder, 42 denotes a roller clamp, and 43 denotes a connector portionthat is connected to a needle for puncturing a container for a drugsolution. This type is a line used in a manner in which it is attachedto the unit section B or C. The drip infusion cylinder 41 is provided sothat the flow state can be observed, and the roller clamp 42 is providedfor adjusting the flow rate.

A unit component E-1-2 (FIG. 11B) is a Y-shaped liquid replacement lineand is provided with a Y-shaped branching line having a stopper 44 and aconnector 45.

A unit component E-1-3 (FIG. 11C) is a port for liquid replacement andincludes a stopper 44, a needle for puncturing a drug solution containeror a connector 45 capable of being connected to another drug solutioninfusion tool.

A unit component E-2-1 (FIG. 11D) is a straight type liquid replacementline having a connector 43 that is connected to a stopper 44 and aneedle for puncturing a drug solution container. Unlike theabove-mentioned three unit sections, this type is connected to the tipportion of the unit section A.

(Unit Section F)

FIGS. 12A and 12B show unit components fit for the unit section F.

A unit component F-1 (FIG. 12A) is a unit component having a veinchamber 51 having a length of about 100-150 mm and including a meshfilter 53. The vein chamber 51 is used for preventing the air fromentering when the purified blood is fed back to the body of a patient.Numeral 54 is a mixing/charging port, 55 denotes a connector connectedto a dialyzer, 56 denotes a pressure monitor connecting portion, and 57denotes a liquid level adjusting portion.

A unit component F-2 (FIG. 12B) has a vein chamber 52 including a meshfilter 53 and has a length of about 100 to 170 mm.

(Unit Section G)

FIGS. 13A to 13D show the unit components fit for the unit section G.

A unit component G-1 (FIG. 13A) includes a vein side cannula connectorcovered with a cover 61 and a small-diameter tube 62 having a fulllength of about 1400-1800 mm and an inner diameter of about 3.5 mm.Similar to the artery side, a priming amount and waste can be reduced byusing the small-diameter tube. The vein side cannula connector is to beconnected to a scalpel connector such as an indwelling needle insertedinto a patient.

Similarly, a unit component G-2 (FIG. 13B) includes a vein side cannulaconnector and a small-diameter tube 65 having a full length of about1800-2400 mm and an inner diameter of about 3.5 mm. The unit componentG-2 further includes a blood connecting mixing/charging port 64 and alock nut 63.

Similarly, a unit component G-3 (FIG. 13C) includes a vein side cannulaconnector and a large-diameter tube 66 having a full length of about1400-1800 mm and an inner diameter of about 4.5 mm.

Similarly, a unit component G-4 (FIG. 13D) includes a vein side cannulaconnector and a large-diameter tube 67 having a full length of about1800-2400 mm and an inner diameter of about 4.5 mm, and further includesa blood collecting mixing/charging port 64 and a lock nut 63.

Although, in FIGS. 13A to 13D, only four kinds of unit components areshown, the number of the unit components prepared in this examplebecomes 16, when calculated by combining all of the elements including asize of the inner diameter of the tube, the length of the tube,existence and nonexistence of the lock nut, and existence andnonexistence of the mixing/charging port. The number of the unitcomponents is greater as compared with the other unit section, however,the cannula connector is automatically determined by selecting the unitcomponent A, and also the length can be automatically determined byselecting the unit section B.

Moreover, it is preferable in the method of configuring a blood circuitfor medical application that the number of the unit sections to bedivided is 4 to 10 in total, because the number in such a range issuitable to be divided. That is, the unit is divided into an artery sideand a vein side, and both the artery side circuit and the vein sidecircuit are respectively divided into a plurality of sections so as tobe provided with a variation. As a result, the blood circuit has four ormore of the unit sections. On the other hand, from the viewpoint of theadvantages in the safety and productivity, the number of the unitcomponents should be relatively small. Therefore, the number of the unitsections is at most 10 and desirably about 7.

Moreover, the number of the unit components included in each unitsection is desired to be in the range from 2 to 5 from the viewpoint ofthe variations and standard unification. Furthermore, it is particularlypreferable that the number of the unit components including the veinside cannula connector is 2 to 20 and the number of the other unitcomponents is 2 to 5. The reason why the number of the number of theunit components including the vein side cannula connector is larger isbecause it is necessary to prepare the different kinds of tubes havingdifferent inner diameters with respect to the returning the blood and itis necessary to prepare the different kinds of tubes for the bloodcollection and the infusion of the drug solution at the vein side. Ingeneral, since the same type connectors are used for the artery sidecannula connector and the vein side cannula connector, the vein sidecomponent may be determined simultaneously by selecting a component atthe side of the artery side. Therefore, a large number of unitcomponents does not lead to the complication of the system necessarily.

As mentioned above, by configuring the blood circuit system whileconsidering the safety in the field of the medical field and theproduction site and the function in advance, the total standard of thecomplicated circuit can be integrated efficiently. Thereby, theautomation at the production site can be realized, to thus supplying theproducts chieply.

As mentioned above, according to the present invention, based on thesystematized blood circuit system, it is possible to configure the bloodcircuit in accordance with the application of use. Furthermore, theoperation of checking the compliance with the desired specification ornot can carried out efficiently without assembling the sample actually.Furthermore, in a case where it is not fit for the desiredspecification, the blood circuit is reconfigured by altering the unitcomponents, and checking thereof is carried out extremely easily.Furthermore, by displaying the entire circuit, the circuit can begrasped as a whole and necessary and unncessary elements can beconfirmed and the necessary elements can be prevented from missing.

The invention may be embodied in other forms without departing from thespirit or essential characteristics thereof The embodiments disclosed inthis application are to be considered in all respects as illustrativeand not limitative, the scope of the invention is indicated by theappended claims rather than by the foregoing description, and allchanges which come within the meaning and range of equivalency of theclaims are intended to be embraced therein.

1. A method of configuring a blood circuit for medical application, theblood circuit being configured by forming a blood circuit system inwhich a blood circuit is divided into a plurality of unit sections and aplurality of selectable unit components are prepared for at least oneunit section, selecting at least one unit component from each unitsection based on the formed blood circuit system; and combining theselected unit components; the method comprising: using a blood circuitsystem database in which data with respect to the unit sections and theunit components contained in the blood circuit system are stored,inputting set conditions including a price with respect to the bloodcircuit to be configured to the computer, extracting a predeterminedrange of candidates of the combinations of the unit components from theblood circuit system database by the computer based on the degree ofcompliance with the input set conditions, displaying a list of thecandidates of the combinations of the extracted unit components on adisplay, inputting a selected assignment of one combination selectedfrom the candidates of the displayed combinations to the computer, anddisplaying an assembly drawing of an entire configuration of the bloodcircuit obtained by combining the selected unit components and at leastone of a full length of the blood circuit or an amount of filled bloodon the display in accordance with the input of the selected assignmentby the use of the blood circuit system database.
 2. The method ofconfiguring a blood circuit for medical application according to claim1, wherein an existing standard database in which a plurality ofexisting standards are stored is further used, the existing standardbeing the combination of the unit components constituting an existingspecific blood circuit, and when the candidates of the combinations ofthe unit components are extracted, an existing standard of thecombination having a high degree of the compliance with the setconditions are extracted also from the existing standard database andadded to the predetermined range of the candidates of the unitcomponents.
 3. An apparatus for configuring a blood circuit for medicalapplication, the blood circuit being configured by forming a bloodcircuit system in which a blood circuit is divided into a plurality ofunit sections and a plurality of selectable unit components are preparedfor at least one unit section, selecting at least one unit componentfrom each unit section based on the formed blood circuit system andcombining the selected unit components; comprising: a blood circuitsystem database in which data with respect to the unit sections and theunit components contained in the blood circuit system are stored, a setconditions input portion for inputting the set conditions including aprice with respect to the blood circuit to be configured, a retrievedcombination candidate display portion for, by the use of the bloodcircuit system database, retrieving candidates of the combinations ofthe unit components based on the degree of the compliance with the inputset conditions, extracting the predetermined range of the retrievedcandidates of the combinations of the unit components, and displayingthe extracted candidates of the combinations, a selection assignmentportion for selecting and supplying one of the candidates of thecombinations of the extracted unit components to an assembly drawingetc. display portion as data of the combinations of the selected unitcomponents, and an assembly drawing etc. display portion for displayingan assembly drawing showing an entire configuration of the blood circuitand at least one of a full length of the blood circuit or an amount offilled blood on the display by the use of the blood circuit systemdatabase on the basis of the data of the combination of the selectedunit components.
 4. The apparatus for configuring a blood circuitcomponent according to claim 3, further comprising: an existing standarddatabase in which a plurality of the existing standards are stored, theexisting standard being the combination of the unit componentsconstituting an existing specific blood circuit, wherein the retrievedcombination candidate display portion retrieves the existing standarddatabase together with the blood circuit system database.
 5. Anapparatus for configuring a blood circuit for medical application, theblood circuit being configured by forming a blood circuit system inwhich a blood circuit is divided into a plurality of unit sections and aplurality of selectable unit components are prepared for at least oneunit section, selecting at least one unit component from each unitsection based on the formed blood circuit system, and combining theselected unit components, comprising: (a) a first apparatus comprising:a blood circuit system database in which data with respect to the unitsections and the unit components contained in the blood circuit systemare stored, a unit section assignment portion for inputting one unitsection on the basis of the blood circuit system database as an assignedunit section, a unit component display portion for extracting data of aplurality of the unit components corresponding to the input assignedunit section and displaying the extracted data on a display, a unitcomponent selection portion for inputting one unit component selectedfrom the displayed unit components, maintaining the data of the selectedunit components of all the unit sections, and supplying the maintaineddata as data of the combination of the selected unit components, and anassembly drawing etc. display portion of displaying an assembly drawingshowing an entire configuration of the blood circuit and at least one ofa full length of the blood circuit or an amount of a filled blood on thedisplay by using the blood circuit system database based on the data ofthe combination of the selected unit components, wherein the data of theselected unit components in the unit component selection portion can bechanged by assigning the unit section in the unit section assignmentportion, (b) a second apparatus comprising an apparatus according toclaim 3, and (c) an operation selection portion for selecting any one ofoperations of either an operation by the unit section assignment portionor an operation by the set conditions input portion.